Tongue Muscular Assessment in Children Referred for Polysomnography in a Context of Suspected Obstructive Sleep Apnea
| Registry | NCT07273019, acronym TMAC-C |
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| Status | Recruiting |
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| Phase | Not applicable |
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| Study type | Interventional; na, single group, masking: none, basic science |
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| Enrollment | 78 (Estimated) |
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| Sponsor | Hospices Civils de Lyon (Other) |
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| Conditions | Obstructive Sleep Apnea |
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| Interventions | Tongue Strength Assessment, Polysomnography, Subjective Assessment of Sleep-Disordered Breathing, Subjective Assessment of Daytime Functioning, Anthropometry, Clinical Examination, Orofacial Praxis Assessment (Other, diagnostic test) |
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| Dates | start 2026-03-26, primary completion 2028-03-26 (estimated), completion 2028-03-26 (estimated), first posted 2025-12-09, last updated 2026-07-30 |
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| Locations | 1 site in France |
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Related Papers Related Patents Related Grants Related Experts
All trials for Obstructive Sleep Apnea All trials of Tongue Strength Assessment All trials of Polysomnography
-Summary
Obstructive sleep apnea (OSA) is part of the sleep-disordered breathing spectrum. Its prevalence in children is 1-5%, and it can have negative consequences at the cardiovascular, cognitive as well as behavioral levels. In children, the first-line treatment is adenotonsillectomy. However, residual obstructive events can persist as the success rate of surgery reaches only 49% in non-obese children. Residual OSA may be explained by multiple sites of obstruction, found in 20-85% children concerned by persistent OSA. Indeed, the tongue appears among one possible primary sites of obstruction. Given the tongue's crucial role in upper-airway patency during sleep, its assessment can inform us about the myofunctional deficits involved in sleep-disordered breathing.
The primary objective of the present study is to assess tongue motor functions in children with sleep-disordered breathing and to compare them to those of healthy children (data collected in a current study (TMAC) conducted at UCLouvain, Belgium; NCT06166680), in order to document possible myofunctional deficits in children with OSA. The hypothesis is that tongue motor functions will be lower in children with sleep-disordered breathing.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Children referred for polysomnography for suspected OSA | Experimental | Other: Tongue Strength Assessment; Diagnostic Test: Polysomnography; Other: Subjective Assessment of Sleep-Disordered Breathing; Other: Subjective Assessment of Daytime Functioning; Other: Anthropometry; Other: Clinical Examination; Other: Orofacial Praxis Assessment | Children aged 4 to 17 years old, referred to the sleep clinic for polysomnography in a context of suspected OSA |
- Tongue Strength Assessment (Other): The following items will be assessed:
1. Tongue peak pressure during 3 seconds of tongue protrusion
2. Tongue peak pressure (i.e., the maximal pressure - Pmax - exerted against the IOPI bulb) during 3 seconds of tongue elevation
3. Tongue pressure (in kPa) exerted against the IOPI (Iowa Oral Performance Instrument) bulb while swallowing
- Polysomnography (Diagnostic test): Patients will undergo full-night polysomnography (including the JAWAC system to record mandibular movements) in the sleep unit of Hôpital Femme-Mère-Enfant (Bron, France) to explore OSA.
- Subjective Assessment of Sleep-Disordered Breathing (Other): The following questionnaires will be filled out:
* OSA-18
* Pediatric Sleep Questionnaire (PSQ)
* Spruyt \& Gozal
* Sleep Disturbance Scale for Children
* Abreu et al.'s questionnaire
- Subjective Assessment of Daytime Functioning (Other): The following questionnaires will be filled out:
* Epworth Sleepiness Scale
* Conners
- Anthropometry (Other): The following measures will be collected via the Quick Tongue-Tie Assessment tool:
1. Maximal mouth opening
2. Maximal mouth opening with tongue to palate
- Clinical Examination (Other): The following variables will be collected during a clinical examination:
1. Age
2. Sex
3. Weight
4. Height
5. BMI
6. Friedman score
7. Mallampati score
8. Medical history
- Orofacial Praxis Assessment (Other): Bucco-Linguo-Facial Motor Skills will be assessed through the test "Motricité Bucco-Linguo-Faciale" (MBLF).
+Outcome measures
Primary outcomes
- Tongue peak pressure during protrusion [Day 1]: Tongue peak pressure during protrusion will be measured using the IOPI (Iowa Oral Performance Instrument) device. Higher tongue pressure is considered a better outcome.
Secondary outcomes
- Tongue peak pressure during elevation and swallowing [Day 1]: Tongue peak pressure during elevation and swallowing movements will be measured using the IOPI (Iowa Oral Performance Instrument) device. Higher tongue pressure is considered a better outcome.
- Tongue mobility restriction [Day 1]: Assessed through the ratio between maximal mouth opening and maximal mouth opening with tongue to palate, measured using the Quick Tongue-Tie Assessment tool. Higher values are considered a better outcome.
- Orofacial praxis [Day 1]: Orofacial praxis will be assessed through the Motricité Bucco-Linguo-Faciale (MBLF) test, which ranges from 0 to 111. Higher scores indicate a better outcome.
- Obstructive apnea-hypopnea index (OAHI) [Day 1]: Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome.
- Central apnea-hypopnea index [Day 1]: Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome.
- Mixed apnea-hypopnea index [Day 1]: Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome.
- Respiratory effort index [Day 1]: Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome.
- Respiratory effort-related arousal index (RERA) [Day 1]: Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome.
- Mean CO2 [Day 1]: Respiratory parameters will be assessed by night polysomnography.
- Max CO2 [Day 1]: Respiratory parameters will be assessed by night polysomnography.
- Time spent with CO2 > 50mmHg [Day 1]: Respiratory parameters will be assessed by night polysomnography.
- Mean SpO2 [Day 1]: Respiratory parameters will be assessed by night polysomnography.
- Desaturation index ≥ 3% [Day 1]: Respiratory parameters will be assessed by night polysomnography.
- Desaturation index ≥ 4% [Day 1]: Respiratory parameters will be assessed by night polysomnography.
- Time spent with SaO2 < 90% [Day 1]: Respiratory parameters will be assessed by night polysomnography.
- Total sleep time [Day 1]: Sleep architecture parameters will be assessed by night polysomnography.
- Sleep onset latency [Day 1]: Sleep architecture parameters will be assessed by night polysomnography.
- Wake after sleep onset [Day 1]: Sleep architecture parameters will be assessed by night polysomnography.
- Duration of sleep N1 [Day 1]: Sleep architecture parameters will be assessed by night polysomnography.
- Duration of sleep N2 [Day 1]: Sleep architecture parameters will be assessed by night polysomnography.
- Duration of sleep N3 [Day 1]: Sleep architecture parameters will be assessed by night polysomnography.
- Duration of REM sleep [Day 1]: Sleep architecture parameters will be assessed by night polysomnography.
- Sleep efficiency [Day 1]: Sleep architecture parameters will be assessed by night polysomnography.
- Score on Abreu's Questionnaire [Day 1]: Total score ranges from 0 to 16. Higher scores indicate a worse outcome.
- Score on the OSA-18 Questionnaire [Day 1]: This questionnaire assesses quality of life associated with sleep-disordered breathing in children. Total score ranges from 18 to 126. Higher scores indicate a worse outcome.
- Score on the Pediatric Sleep Questionnaire [Day 1]: This questionnaire assesses symptoms and repercussions of sleep-disordered breathing in children. Total score ranges from 0 to 22. Higher scores indicate a worse outcome.
- Score on the Spruyt & Gozal Questionnaire [Day 1]: This questionnaire assesses sleep-disordered breathing in children. Total score ranges from 0 to 4. Higher scores indicate a worse outcome.
- Score on the Sleep Disturbance Scale for Children [Day 1]: This questionnaire assesses sleep disturbance in children. Total score ranges from 25 to 125. Higher scores indicate a worse outcome.
- Score on the French Version of the Sleepiness Scale for Adolescents [Day 1]: This questionnaire assesses excessive daytime sleepiness. Total score ranges from 25 to 125. Higher scores indicate a worse outcome.
- Score on the Conners Rating Scale [Day 1]: This questionnaire assesses hyperactivity. Total score ranges from 0 to 30. Higher scores indicate a worse outcome.
- Medical history [Day 1]: Medical history is conducted by a doctor. It will be used to determine the type of OSA (craniofacial and/or syndromic comorbidities classify OSA as type III; otherwise, OSA is type II in the presence of obesity, or type I in the absence of obesity).
+Eligibility
Sex: All, ages: 4 Years to 17 Years
Inclusion Criteria:
* With suspected sleep-disordered breathing
* Referred for polysomnography
* Affiliated to a social security scheme
* With informed consent from both legal representatives
Exclusion Criteria:
* Insufficient comprehension of French language
* Regarding patients with suspected OSA type I or II:
* Neurological, cardiac, or unstable respiratory conditions other than sleep disorders and their repercussions
* Any deficit possibly impacting measurements according to the investigator (e.g., psychiatric condition)
* Malformation of the skull, the upper airway or the oral cavity
* Regarding patients with suspected OSA type III:
* Any deficit possibly impacting measurements according to the investigator (e.g., psychiatric condition)
* Intellectual deficit impeding the understanding of instructions
+Locations (1)
| Facility | City | Country | Status |
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| Hôpital Femme-Mère-Enfant : Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant | Bron | France | Recruiting |